Position Title Clinical Trials Manager Maghreb

Job ID    130155BR
Division    Pharma
Business Unit    Asia, Middle East & Africa
Country    Morocco
Work Location    Casablanca
Company/Legal Entity    Morocco Novartis Pharma Maroc SA, Casablanca
Functional Area    Development & Medical
Job Type    Full Time
Employment Type    Regular
Job Description    Job Purpose

• Responsible for planning, initiation, conduct and reporting of all local Novartis sponsored clinical trials in the Maghreb cluster.

• These activities include preparation and approval of essential study documents, study start-up activities, monitoring participating sites, ensuring the studies are conducted in accordance with ICH/GCP, local regulations and Novartis internal SOPs, CRF collection, data management and study results reporting within the proper timelines and at high standards. The incumbent is responsible for the Phase IV budget planning, tracking and spend.

• These activities may require selection and management of the 3rd parties in accordance with GCP, local regulations and Novartis SOPs. Depending on the intensity of the Phase IV activities in the cluster, additional CRAs (in-house or 3rd party) may be hired. The incumbent will be responsible for these CRAs' performance.

Major Activities

1. Plans studies in accordance with the local BOS plans. Liaise with the local brand teams, regional office and 3rd parties to ensure timely initiation of the local studies
2. Collaborates with Medical Adviser or MSL to prepare study concept sheets, clinical protocols and related documents.
3. Ensures that all trial deliverables are met according to timelines, budget, quality standards and operational procedures
4. In collaboration with the country DRA departments and medical associates prepares the study files for submission to health authorities and ethics committees
5. Responsible for set up and maintenance of the Trial Master File for assigned studies (can be delegated to CRA).
6. Ensures that monitoring of participating sites is conducted as per local laws, GCP and Novartis SOPs
7. Coordinates all aspects of contacts with the 3rd parties (e.g. CROs) including quality assurance, contract management, budget tracking.
8. Coordinates pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved.
9. Contributes to identification and evaluation of new centers suitable for performing studies in healthy volunteer and patients.
10. Hires, trains, supervises team of CRAs and allocates trials in assigned territory.
11. Assures that required level of knowledge and skills is present. Identifies skills and competency gaps. Works with training team to develop training plans and coordinate training as needed.
12. Supports the CRA on study related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects eligibility.
Key Performance

1. Deliver strategic input for operations to trials / programs and processes for Novartis operations.
2. Deliver trials / programs for the countries on time, with quality data and in budget.
3. Feedback of external (investigators) and internal customers.
Minimum requirements    Education (minimum/desirable): MD, or PharmD, or PhD, or degree in life science (e.g. biology)

Languages: Arabic, French, English – fluent


Experience/Attributes/
Professional requirements:
1. At least 6 years experience in clinical research with proven proficiency in trial execution and drug development.
2. Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.
3. Expert knowledge of international standards (GCP/ICH), local regulations and Novartis SOPs.
4. Proven leadership skills and ability to manage teams
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